Study of the Effect of Everolimus Immunosuppressive Combination Therapies on Renal Function When Used as a Maintenance Treatment for Liver Transplant Patients.

Phase 3

Withdrawn

• Conditions: Liver Transplantation
• Interventions: Drug: TAC withdrawal; Drug: Everolimus with reduced TAC

• Registration Number: NCT03596970
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

A 24-month multi-center, open-label, randomized, controlled study to evaluate the evolution of renal function in maintenance liver transplant recipients receiving everolimus plus reduced TAC or everolimus plus mycophenolate mofetil (MMF)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-06-25
• Study Start: 2015-09
• Status Verified: 2018-07
• Study First Submitted QC: 2018-07-13
• Last Update Submitted: 2018-07-13
• Study First Posted: 2018-07-24
• Last Update Posted: 2018-07-24
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Patients willing and capable of providing written informed consent for study participation.
• Adults 18 to 70 years of age.
• Liver allograft from a deceased or living donor.
• Treated with a CNI containing immunosuppressive regimen.
• Liver transplant 6 to 24 months prior to screening.
• Estimated kidney function between chronic kidney disease (CKD) IIIb/ 30 mL/min < eGFR < CKD II/60 mL/min with deteriorating renal function.
• Acceptable graft function (according to liver enzymes (AST / ALT) and total bilirubin).

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Exclusion Criteria

• Multiple solid organ transplant recipients
• Active chronic inflammatory bowel disease and recurrent autoimmune hepatitis
• Malignant diseases other than neoplasms of the skin.
• Patient on other investigational drug or presence of any hypersensitivity to the interventional drug.
• Pregnant or nursing (lactating) women.
• Women of child-bearing potential (physiologically capable of becoming pregnant, unless they are using effective methods of contraception).
• Anemia, thrombocytopenia, leucopenia, uncontrolled hyperlipidemia or proteinuria
• HIV positivity

Other protocol-defined inclusion/exclusion criteria may apply.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Everolimus with MMF (TAC-withdrawal)	TAC withdrawal	Everolimus (RAD001) with MMF and Steroids
Everolimus with reduced TAC	Everolimus with reduced TAC	Everolimus (RAD001) with reduced TAC and Steroids

Primary Outcome Measures

Name	Time	Method
Renal Function	Randomization to Month 6	The primary variable will be the mean change in renal function assessed by eGFR from randomization to Month 6.

Secondary Outcome Measures

Name	Time	Method
Efficacy (tBPAR, graft loss, death, loss to follow-up)	To Month 6	Composite efficacy failure of tBPAR, graft loss, death or loss to follow-up and each of its components at month 6 will be analysed per event rate estimates, Kaplan-Meier and regression models. The time to the first occurrence of the event will be calculated from the randomization date.